Study Design

Primary Outcomes

Number of participants who attain the Lupus Low Disease Activity State (LLDAS)

time frame:
52 weeks

Secondary Outcomes

Measure

Number of patients achieving a SLE Responder Index (SRI) Response

time frame:
52 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Key Inclusion Criteria:
- Clinical diagnosis of SLE by ACR criteria.
- Active SLE disease.
- Autoantibody-positive.
- On stable SLE treatment regimen.
Key Exclusion Criteria:
- Pregnant or nursing
- Have received treatment with any B cell targeted therapy.
- Have received treatment with a biological investigational agent in the past year.
- Have received IV cyclophosphamide within 180 days of Day 0.
- Have severe lupus kidney disease.
- Have active central nervous system (CNS) lupus.
- Have required management of acute or chronic infections within the past 60 days.
- Have current drug or alcohol abuse or dependence.
- Have a historically positive test or test positive at screening for HIV, hepatitis B,
or hepatitis C.

Additional Information

Official title

Utility of a Measure of Lupus Low Disease Activity State (LLDAS) in SLE: Pooled Analysis of the HGS1006-C1056 (BLISS-76) and HGS1006-C1057 (BLISS-52) Trials

Description

Systemic Lupus Erythematosus (SLE) is a multisystem autoimmune disease with an estimated
incidence of 5-50 cases per 100,000 people. Despite advances in therapy, there is still
significant mortality and morbidity associated with this disease. There have been no clearly
defined treatment goals in SLE, hindering the development of treat to target approaches and
evaluation of new therapies. Although remission is aimed for, it rarely occurs. A more
achievable clinical state and treatment goal of low disease activity has been described
recently and a preliminary single centre validation study has demonstrated its association
with improved outcomes. This endpoint is termed Lupus Low Disease Activity State (LLDAS).
The proposed study will assess the discriminant validity of the proposed LLDAS criteria in a
clinical trial dataset. The objective of the research is to validate the Lupus Low Disease
Activity State (LLDAS) tool as a study endpoint in SLE. The data available from the
belimumab BLISS trials will be used to evaluate the LLDAS score.
The outcome of these studies will be validation of the LLDAS instrument in a clinical trial
dataset, for the first time. This will allow future studies to consider incorporating LLDAS
attainment as a trial endpoint, for example allowing comparison of frequency of achieving
LLDAS to discriminate between treatments.
The findings will be interpreted using statistical methods and will be published / presented
to the public and to peers via peer-reviewed publications, conference presentations, and
where relevant the lay media.

Trial information was received from ClinicalTrials.gov and was last updated in September 2016.